Methylprednisolone

Product NDC
45865-104
11-digit product format
458650104
Labeler code
45865
Product ID
45865-104_b5a60209-13e1-4931-e053-2995a90a8474
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA040194
Marketing category
ANDA
Marketing start
1997-10-31
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-104-212025-01-30C16284748780-12cef2736-9209-d83d-e063-dadaa90ab31fMethylPREDNIsolone Tablets, USP 4 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-104-21Methylprednisolone1 in 1 CARTONTABLET11
45865-104-21Methylprednisolone21 in 1 DOSE PACKTABLET211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-104METHYLPREDNISOLONE TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20201219_b5a61225-4086-0a50-e053-2995a90acde1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259966methylPREDNISolone 4 MG Oral TabletPSNb5a61225-4086-0a50-e053-2995a90acde11
259966methylprednisolone 4 MG Oral TabletSCDb5a61225-4086-0a50-e053-2995a90acde11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-104-21458650104211 DOSE PACK in 1 CARTON (45865-104-21) > 21 TABLET in 1 DOSE PACK1 dose pack1997-10-310000-00-00NoNoCurrent